Actively Recruiting
Evaluation of the Efficacy and Safety of the Mi-thos4 Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk
Led by Shanghai NewMed Medical Co., Ltd. · Updated on 2025-02-13
122
Participants Needed
3
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the safety and performance of the Mi-thos4 Mitral Heart Valve together with the Mi-thos4 Transcatheter Delivery System in patients with severe mitral valve disease who are at high surgical risk. This prospective, single-arm, multicenter clinical study aims to assess how well this device works and its safety profile in this patient group. Participants receive the Mi-thos4 valve replacement via a transcatheter delivery system using a transapical approach. The study includes only one treatment group where patients undergo this minimally invasive valve replacement procedure. During the study, participants will be monitored for up to five years. Researchers will evaluate survival without all-cause mortality at one year as the primary outcome. Secondary assessments include mortality at multiple time points, rates of severe adverse events, heart function ratings using the NYHA classification, and quality of life measured by the Kansas City Cardiomyopathy score. Safety and performance will be closely followed through scheduled evaluations.
CONDITIONS
Brief Title
Mi-thos® Transcatheter Mitral Valve Replacement Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe mitral valve regurgitation grade 3 or higher
- High surgical risk for open mitral valve surgery
- Age 65 years or older
- Life expectancy greater than 12 months
- Not eligible for surgery as assessed by a multidisciplinary cardiac team
- Signed informed consent form
You will not qualify if you...
- Previous cardiac mitral valve surgery
- Active infections requiring antibiotic treatment
- Untreated clinically significant coronary artery disease
- Pulmonary hypertension with systolic pressure over 70 mmHg
- Severe right heart failure
- Left ventricular ejection fraction below 25%
- Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
- Dialysis patients
- Severe coagulopathy
- Contraindications to anticoagulant drugs
- Stroke or transient ischemic attack within 30 days
- Presence of intracardiac mass or thrombus in the left ventricle or atrium
- Requires surgery or intervention for other valvular lesions
- Severe macrovascular disease requiring surgery
- More than 70% carotid artery stenosis
- Allergy to contrast agents, nickel-titanium alloys, or bovine-derived products
- Severe neurological disorders affecting cognitive ability
- Severe thoracic deformities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with immediate post-operative care
Participants undergo transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system.
1 procedure visit and closely monitored immediate post-operative period
Duration - Up to 5 years
Participants are monitored for safety and heart function improvements after the valve replacement procedure.
Visits at 30 days, 6 months, 1 year, and annually up to 5 years
Trial Site Locations
Total: 3 locations
1
Fuwai hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
3
Xijing hospital
Xi’an, Shanxi, China, 710032
Actively Recruiting
Research Team
W
Wang chunyang, CRA
X
Xie xuyang, c
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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